Beijing, China – 20 Sep 2026 – The China National Institute for Food and Drug Control (NIFDC) published its weekly Batch Release Information Publicity Table covering September 14–20, 2026, granting release approval (予以签发) to 86 batches of vaccines, in‑vitro diagnostic reagents, and blood products submitted by 26 marketing authorization holders. All batches were certified by the NIFDC as the issuing lot‑release authority, with no refusals recorded in the publicity table for the period.
Batch Release Snapshot
| Item | Detail |
|---|---|
| Authority | China National Institute for Food and Drug Control (NIFDC) |
| Publication Type | Weekly Batch Release Information Publicity Table |
| Coverage Period | 14–20 September 2026 |
| Total Batches Certified | 86 (all “release approved”) |
| Composition | 72 vaccine batches, 12 diagnostic reagent batches, 2 blood product batches (Human Coagulation Factor VIII) |
| Marketing Authorization Holders | 26 domestic and foreign manufacturers |
| Imported Products | 2 batches (DiaSorin Italia S.p.A. UK Branch – HBsAg ELISA kits, import batch‑release certificates) |
| Expiry Date Range | March 2027 (nasal‑spray influenza vaccine) through June 2029 (Human Coagulation Factor VIII) |
| Lot Sizes | Not disclosed |
Category Breakdown – 86 Certified Batches
| Product Category | Batches | Marketing Authorization Holder(s) |
|---|---|---|
| Recombinant Hepatitis B Vaccine (Hansenula polymorpha) | 18 | AIM Changxin Biological Pharmaceutical (sole supplier this cycle) |
| Lyophilized Human Rabies Vaccine (Vero Cell) | 15 | Fosun Yalifeng Dalian (6), Jiangsu Kangrun (3), Shanghai Rongsheng (3), Changchun Zhuoyi (3) |
| Measles‑Mumps‑Rubella (MMR) Live Attenuated Combined Vaccine | 9 | Beijing Institute of Biological Products |
| Influenza Virus Split Vaccine | 6 | Anhui Zhifei Longcoma (3), Zhejiang Tianyuan (2), Hualan Biological Vaccine (1) |
| Bivalent HPV Vaccine (Pichia pastoris) | 4 | Yuxi Walvax (Zerun) Biotechnology |
| Adsorbed Acellular DTP Combined Vaccine | 4 | Chengdu Institute of Biological Products |
| HBsAg Diagnostic Kit (ELISA) | 4 | DiaSorin Italia S.p.A. UK Branch (2, imported), Shanghai Kehua (2) |
| Lyophilized Human Rabies Vaccine (Human Diploid Cell) | 3 | Chengdu Kanghua (2), Chengda Biological Benxi (1) |
| Influenza Virus Subunit Vaccine | 3 | Zhongyi Anke (2), Jiangsu Zhonghui Yuantong (1) |
| HCV Antibody Diagnostic Kit (ELISA) | 3 | Beijing Jinhao (1), Shanghai Kehua (1), Intco XinChuang Xiamen (1) |
| EV71 Inactivated Vaccine (Human Diploid Cell) | 3 | Institute of Medical Biology, Chinese Academy of Medical Sciences |
| Meningococcal ACYW135 Polysaccharide Conjugate Vaccine (CRM197 carrier) | 2 | CanSino Biologics |
| Meningococcal A+C Polysaccharide Conjugate Vaccine | 2 | Chengdu Oulin Biotech |
| Nasal‑Spray Live Attenuated Influenza Vaccine | 2 | Changchun Baike Biological Technology |
| Treponema pallidum Antibody Diagnostic Kit (ELISA) | 2 | Shanghai Kehua (1), Intco XinChuang Xiamen (1) |
| HIV Antibody Diagnostic Kit (ELISA) | 2 | Shanghai Kehua |
| Human Coagulation Factor VIII | 2 | China Resources Boya Biopharmaceutical |
| Sabin Strain Inactivated Polio Vaccine (Vero Cell) | 1 | Sinovac Biotech |
| HIV Antigen/Antibody Diagnostic Kit (ELISA) | 1 | Zhuhai Livzon Diagnostics |
Manufacturer & Product Highlights
- Hepatitis B leadership: AIM Changxin Biological Pharmaceutical, an affiliate of the AIM (Vacuna) vaccine group, accounted for all 18 recombinant hepatitis B (Hansenula polymorpha) batches certified this week — the largest single‑product haul of the cycle.
- Rabies segment depth: A combined 18 rabies vaccine batches were released across seven manufacturers, spanning both mainstream Vero‑cell platforms and premium human diploid cell products from Chengda Biological (Benxi) and Chengdu Kanghua, underscoring sustained competition in China’s post‑exposure prophylaxis market.
- CanSino quadrivalent conjugate: CanSino Biologics (HKEX: 6185; SSE STAR: 688185) secured release of two lots of its ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 carrier) — certificates 批签中检20262481/2482, with dual sub‑lot structure (MAC/MYW components), expiring October 2028.
- Sinopharm network output: Beijing Institute of Biological Products (9 MMR batches) and Chengdu Institute of Biological Products (4 acellular DTP batches), both under China National Biotec Group (CNBG) of Sinopharm, dominated pediatric Expanded Programme on Immunization (EPI) categories.
- Sinovac polio: Sinovac Biotech (private) received release for one batch of its Sabin‑strain inactivated polio vaccine (Vero cell), supporting national polio eradication maintenance immunization.
- Walvax HPV supply: All four bivalent HPV vaccine (Pichia pastoris) batches came from Yuxi Walvax (Zerun) Biotechnology, the manufacturing arm of Walvax Biotechnology (SZSE: 300142), extending the two‑dose domestic HPV franchise.
- Blood products: China Resources Boya Biopharmaceutical (SZSE: 300294) certified two Human Coagulation Factor VIII lots with the longest shelf life in the table (expiry June 2029).
- Diagnostics breadth: Shanghai Kehua Bio‑engineering led IVD releases with batches across HBsAg, HCV, HIV, and syphilis ELISA panels; Zhuhai Livzon Diagnostics (under Livzon Pharmaceutical Group) contributed an HIV antigen/antibody combo kit.
Market Impact & Outlook
- Regulatory Gatekeeping: China mandates lot‑by‑lot batch release for all vaccines and blood products — every commercial lot must carry NIFDC certification before market entry, making the weekly publicity table a high‑fidelity, near‑real‑time indicator of domestic vaccine supply flow.
- Flu Season Build‑Up: With 11 influenza vaccine batches across split, subunit, and nasal‑spray live‑attenuated formats from six manufacturers, the cycle signals active stockpiling ahead of the northern‑hemisphere autumn–winter immunization campaign.
- Pediatric Program Continuity: The concentration of MMR and DTP releases from CNBG institutes points to steady replenishment of state‑procured EPI vaccine inventories for the autumn enrollment vaccination window.
- Import Channel Functioning: The two DiaSorin HBsAg kit certifications (批签中(进)检 series) confirm the import batch‑release pathway remains routine for foreign IVD suppliers serving Chinese blood‑screening and hospital markets.
- Supply Quantification Limits: The publicity discloses certificates, batch numbers, and expiry dates but not lot volumes; dose‑level supply estimates cannot be derived from this release.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding vaccine supply continuity, procurement timing, and seasonal immunization demand in China. Batch‑release certification confirms regulatory clearance of specific lots only; actual market availability, tender awards, and distribution volumes may differ based on procurement dynamics and manufacturer planning..-China Health Reform Pulse
Policy Source: https://www.nidc.org.cn/directory/web/nifdc/xxgk/ggtzh/jwgk/shwzhppfgg/202609221454042215080.html